Sr Regulatory Affairs Specialist
Sr Regulatory Affairs Specialist
Posted on :
06-02-2025
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1 Vacancy
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Job Description
Job Title: Sr. Regulatory Affairs Specialist
Job Location: Gurugram Haryana India
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: Associate
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine!
We are proud to offer you our total rewards package which includes bonuses healthcare insurance benefits retirement programs wellness programs as well as service and performance awards – not to mention various social and recreational activities all of which are location specific.
Job Responsibilities
BS in Engineering Science or related degree; or MS in Regulatory Science
58 yrs experience
Stryker is a global leader in medical technologies and together with its customers is driven to make healthcare better. The company offers innovative products and services in MedSurg Neurotechnology Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world Stryker impacts more than 150 million patients annually.
We are proud to offer you our total rewards package which includes bonuses healthcare insurance benefits retirement programs wellness programs as well as service and performance awards – not to mention various social and recreational activities all of which are location specific.
Job Responsibilities
- Identifies information sources and resources for local regional and global regulations
- Collects organizes and maintains files on local regional and global regulatory intelligence and other related information
- Monitors the regulatory environment (specific regulations guidance and other relevant information by product types geography etc.)
- Provides information used to evaluate proposed products for regulatory classification and jurisdiction
- Researches requirements (local national international) applicable guidance and standards and options for regulatory submissions approval pathways and compliance activities
- Assists in the development of regulatory procedures and SOPs
- Collects and organizes information on requirements for regulatory quality preclinical and clinical data to meet applicable regulations
- Organizes materials from preclinical and clinical studies for review and assists in the review process
- Compiles and organizes materials for presubmission reports and communications
- Assists in the preparation of dossiers and presubmission and submission packages for regulatory agencies
- Tracks the status of applications under regulatory review and provides updates to the regulatory team
- Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
- Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
- Time management skills writing coordination and execution of basic regulatory items.
- Coordinate and support technical and scientific regulatory activities.
- Under supervision performs work that is varied and that may be somewhat difficult in character but usually involves limited responsibility.
- Some evaluation originality or ingenuity is required.
- Clearly conveys information to peers supervisors and other stakeholders
- Assists in the preparation for meetings with regulatory agencies and other stakeholders
- Assists in the preparation of briefings and other information documents
- Communicates information on regulatory requirements to other departments and business units
- Composes routine communications with regulators and other key stakeholders
- Creates clarity and direction amid complexity and develops solutions for self colleagues and the organization
- Seeks out diverse ideas opinions and insights and applies them in the workplace
- Connects and relates well with people who think and act differently than oneself
- Embraces scrutiny and accepts feedback as opportunity to learn and improve
BS in Engineering Science or related degree; or MS in Regulatory Science
58 yrs experience
Stryker is a global leader in medical technologies and together with its customers is driven to make healthcare better. The company offers innovative products and services in MedSurg Neurotechnology Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world Stryker impacts more than 150 million patients annually.
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Employment Type
Full Time
Key Skills
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